MultiPulse TFL

Asclepion Laser Technologies GmbH

Country / region:United States (US)Submission type:Special

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

3

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K253100
Device name
MultiPulse TFL
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2025-09-24
Decision date
2025-10-23
Submission type
Special
Technology type
Thulium fiber(AI inferred)
Clinical applications
Surgical cuttingOtherVascular treatmentSkin resurfacing
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

MultiPulse TFL Laser system and its fibre optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy.

Urology

Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Urethral Strictures
- Bladder Neck Incisions (BNI)
- Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors
- Ablation of Benign Prostatic Hypertrophy (BPH)
- Transurethral incision of the prostate (TUIP)
- Laser Resection of the Prostate
- Laser Enucleation of the Prostate
- Laser Ablation of the Prostate
- Condyloma
- Lesions of external genitalia
- Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
- Treatment of distal impacted fragments remaining in the ureters following lithotripsy
- Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones
- Endoscopic fragmentation of renal calculi
- Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed

Gastroenterology

Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Appendectomy
- Polyps
- Biopsy
- Gall Bladder calculi
- Biliary/Bile duct calculi
- Ulcers
- Gastric ulcers
- Duodenal ulcers
- Non Bleeding Ulcers
- Pancreatitis
- Hemorrhoids
- Cholecystectomy
- Benign and Malignant Neoplasma
- Angiodysplasia
- Colorectal cancer
- Telangiectasia
- Telangiectasia of the Osler-Weber Renu disease
- Vascular Malformation
- Gastritis
- Esophagitis
- Esophageal ulcers
- Varices
- Colitis
- Mallory-Weiss tear
- Gastric Erosions.

Arthroscopy

Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) including:
- Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including:
- Percutaneous Laser Disc Decompression/Discectomy
- Foraminoplasty
- Ablation and coagulation of soft vascular and nonvascular tissue in minimally invasive spinal surgery.

Gynecology

Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation) including:
- Endometrial polyps and uterine septum by incision, excision, ablation and/or vessel coagulation
- Soft tissue excision procedures such as excisional conization of the cervix.

ENT

Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including:
- Endonasal/sinus Surgery
- Partial turbinectomy
- Polypectomy
- Dacryocystorhinostomy
- Frontal Sinusotomy
- Ethmoidectomy
- Maxillary 

Intended Use

MultiPulse TFL Laser system and its fibre optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy.

Device Description

The MultiPulse TFL laser system and its fiber optic delivery system is a laser Class IV, operating in CW or pulsed mode at a wavelength of 1940 nm. The laser power up to 200W is transmitted through different optical fibers. Besides of the optical bench the device consists of a power supply, a water cooling unit and a control electronic. The device is operated by a touch screen and a foot switch.

Summary parsed at:2026-06-01 05:24:32 UTC

Predicate devices

3

K253100 references 3 predicate/reference devices

Cited as predicate

0

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